Manufacturing Quality Assurance (MQA) Supervisor

Description

SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.

Summary:

The Manufacturing Quality Assurance (MQA) Supervisor position directs a team of QA Specialists trained in Manufacturing Quality Assurance. The MQA team is responsible for the quality involvement and oversight of routine operations such as compounding, inspection, labeling and testing activities on site. This team is also responsible for Batch Record review and final product disposition. The MQA Supervisor provides support to the MQA team through scheduling and coordinating MQA activities and driving timely and efficient Batch Record review and product disposition. In this position, the MQA Supervisor also supports the Organization though process-improvement and optimization initiatives as well as drives compliance to the regulations and site procedures.

Essential functions:

• Responsible for the MQA program, which includes scheduling and coordinating MQA activities and the assisting with the resolution of any issues that develop
• Responsible for assisting the MQA team in assessing the impact of observations made during MQA oversight
• Ensures MQA support and oversight is provided during Media Fill and Shut-down activities.
• Maintains strong communication network within the MQA team and in all areas of the organization
• Responsible for timely batch release, which includes scheduling and coordinating batch review and release activities and the assisting with the resolution of any issues that develop
• Tracks batch record related corrections and right first-time metrics, reports these metrics to their respective departments, and works with area owners to reduce corrections, improve RFT and ensure an efficient batch release process is maintained
• Performs Quality Assurance final review of validation protocols and reports, quality event investigations, change controls, CAPAs and SOPs
• Proactively looks for opportunities to identify change, increase efficiency, influence decisions, and deliver results while ensuring compliance
• Trains, mentors, and develops direct reports
• Additional responsibilities as assigned

Requirements

Required Qualifications & Experience:

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 3 years of supervisory experience required
• 5 years working experience in pharmaceutical, medical device or other related industries

Desired Knowledge, Skills, and Abilities:

• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Thorough knowledge and understanding of cGMP.
• Experience in pharmaceutical quality unit and aseptic processing preferred.
• Demonstrated skills/abilities in conducting and documenting investigations.
• Is goal and task oriented, has strong sense of urgency.
• Some exposure to regulatory agency inspections (e.g., FDA, notified bodies, etc.).
• Familiarity with regulatory requirements for 503(b) sterile compound outsourcing facilities preferred
• Proven ability to work cross-functionally to achieve business outcomes

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.